Fortical Side Effects

Generic Name: calcitonin

Please note - some side effects for Fortical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fortical - for the Consumer

Fortical Spray

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fortical Spray:

Back or joint pain; headache; runny nose; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Fortical Spray:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); nasal irritation, soreness, or pain; nosebleeds; sores in nose.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Fortical Side Effects - for the Professional

Fortical

The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to calcitonin-salmon nasal spray (N=341) and to placebo nasal spray (N=131), and reported in greater than 3% of calcitonin-salmon nasal spray treated patients are presented in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).

Adverse Reactions Occurring in at Least 3% of Postmenopausal Patients Treated Chronically

Adverse Reaction	Calcitonin-Salmon Nasal Spray N=341 % of Patients	Placebo N=131 % of Patients
* Symptom of nose includes: nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/blocked, small wound, bleeding wound, tenderness, uncomfortable feeling and sore across bridge of nose.
Rhinitis	12.0	6.9
Symptom of Nose*	10.6	16.0
Back Pain	5.0	2.3
Arthralgia	3.8	5.3
Epistaxis	3.5	4.6
Headache	3.2	4.6

In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with calcitonin-salmon nasal spray. Adverse events reported in 1%-3% of patients are identified with an asterisk(*). The remainder occurred in less than 1% of patients. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to calcitonin-salmon nasal spray has not been established.

Body as a whole – General Disorders: influenza-like symptoms*, fatigue*, edema (facial, peripheral, and generalized), fever

Integumentary: erythematous rash*, skin ulceration, eczema, alopecia, pruritus, increased sweating

Musculoskeletal/Collagen: arthrosis*, myalgia*, arthritis, polymyalgia rheumatica, stiffness

Respiratory/Special Senses: sinusitis*, upper respiratory tract infection*, bronchospasm*, pharyngitis, bronchitis, pneumonia, coughing, dyspnea, taste perversion, parosmia, nasal congestion, sneezing, allergic rhinitis, nasal odor, mucosal excoriation, rhinitis ulcerative

Cardiovascular: hypertension*, angina pectoris*, tachycardia, palpitation, bundle branch block, myocardial infarction

Gastrointestinal: dyspepsia*, constipation*, abdominal pain*, nausea*, diarrhea*, vomiting, flatulence, increased appetite, gastritis, dry mouth

Liver/Metabolic: cholelithiasis, hepatitis, thirst, weight increase

Endocrine: goiter, hyperthyroidism

Urinary System: cystitis*, pyelonephritis, hematuria, renal calculus

Central and Peripheral Nervous System: dizziness*, paresthesia*, vertigo, migraine, neuralgia, agitation

Hearing/Vestibular: tinnitus, hearing loss, earache

Vision: abnormal lacrimation*, conjunctivitis*, blurred vision, vitreous floater, visual disturbance

Vascular: flushing, cerebrovascular accident, thrombophlebitis

Hematologic/Resistance Mechanisms: lymphadenopathy*, infection*, anemia

Psychiatric: depression*, insomnia, anxiety, anorexia

Immune System Disorders: hypersensitivity, anaphylaxis and anaphylactic shock

Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with calcitonin-salmon nasal spray than in those patients treated with injectable calcitonin. Nausea, with or without vomiting, which occurred in 1.8% of patients treated with the nasal spray (and 1.5% of those receiving placebo nasal spray) occurs in about 10% of patients who take injectable calcitonin-salmon. Flushing, which occurred in less than 1% of patients treated with the nasal spray, occurs in 2-5% of patients treated with injectable calcitonin-salmon. Although the administered dosages of injectable and nasal spray calcitonin-salmon are comparable (50-100 units daily of injectable versus 200 units daily of nasal spray), the nasal dosage form has a mean bioavailability of about 3% (range 0.3%-30.6%) and therefore provides less drug to the systemic circulation, possibly accounting for the decrease in frequency of adverse reactions.

The collective foreign marketing experience with calcitonin-salmon nasal spray does not show evidence of any notable difference in the incidence profile of reported adverse reactions when compared with that seen in the clinical trials.

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Side Effects by Body System - for Healthcare Professionals

General

Side effects are often mild, but commonly occur in about 10% of patients and may occur in up to 30%. About one third of treated patients discontinue the drug due to side effects. Diminished adverse effects occur with the subcutaneous route versus the intramuscular route. After injection, side effects generally occur within an hour.

Calcitonin is a large, manufactured peptide. A certain percentage of what is produced during manufacturing may be "error peptides" which may increase or change the side effects.

Gastrointestinal

Nausea is the most common symptom and occurs in about 10% to 21% of patients. Vomiting, diarrhea, anorexia, and abdominal discomfort are also common effects of calcitonin. A metallic taste is reported.

A 71-year-old with Paget's disease was treated with 100 intl units of synthetic salmon calcitonin five times a week. After each injection she experienced nausea, vomiting, and severe shivering. Administration of the 5HT antagonist pizotifen eliminated the side effects.

Cardiovascular

Cardiovascular side effects including tingling of the hands and flushing of the palms, soles, face, or ears are common. A feeling of pressure in the chest may occur.

Nervous system

Within 90 minutes of a subcutaneous injection of 100 intl units of synthetic salmon calcitonin, a 35-year-old woman developed widespread fine tremor which lasted an hour. The reaction could be repeated with a different batch of the drug but not with placebo.

Central nervous system side effects of shivering, chills, paresthesias, dizziness, and headache have been reported. Widespread tremor occurred in one patient after subcutaneous administration of salmon calcitonin. Tetany has been reported rarely.

Local

Local side effects including pain, wheals, and erythema at the injection site have been reported. Local reactions are less likely after injection of synthetic human calcitonin than with the synthetic salmon preparation.

Respiratory

Respiratory side effects of shortness of breath and nasal congestion occur infrequently. Rhinorrhea, mild nose bleeds, and nasal dryness may occur with nasal administration.

Immunologic

Antibodies may develop to extracted or synthetic calcitonin products after chronic use. The time to antibody development is variable and patient dependent. Antibodies have been reported with the salmon preparation, and rarely to the human product. Antibody development will render a patient resistant to therapy.

Metabolic

Hyperglycemia has been reported as a metabolic side effect in patients with Paget's disease. Impaired glucose tolerance may occur in healthy volunteers. Diabetics may lose control of blood sugar.

Metabolic acidosis and hypocalcemia may occur. Transient increases in water and sodium excretion may occur.

A study of 20 post-menopausal women on calcitonin for osteoporosis for 6 months showed that about seven hours after administration of 100 intl units (intramuscularly) of synthetic salmon calcitonin a mild metabolic acidosis developed.

Renal

Renal side effects including polyuria and urinary frequency may occur in 5% to 10% of patients. Abnormal urinary sediment (but not proteinuria or reduced creatinine clearance) is a rare side effect.

Dermatologic

A 66-year-old woman received a total of 5600 intl units of intranasal synthetic salmon calcitonin for treatment of osteoporosis. Within one month she developed disseminated granuloma annulare (DGA). The calcitonin was continued for one month after symptoms of DGA were recognized. Lesions did not disappear immediately but continued for 10 months. The relationship was temporal but could not be proved as causal.

Dermatologic side effects including various rashes, urticaria, and flushing and itching of the palmar and plantar surfaces have been reported. Flushing is a common effect. A single case of disseminated granuloma annulare was temporarily related to synthetic salmon calcitonin use. It is a rare effect.

Musculoskeletal

Musculoskeletal side effects including a bilateral deformation of the alar nasal cartilages have been rarely reported after intranasal use. Musculoskeletal weakness may occur.

A 58-year-old woman being treated for osteoporosis with 100 intl units of salmon calcitonin spray per nostril per day developed a progressive bilateral deformation of the alar nasal cartilages. Two depresses, symmetric areas appeared after 4 months. There was nasal septum deformation. The relationship was temporal but could not be proven as causal.

Hypersensitivity

Hypersensitivity side effects have included a few cases of serious allergic-type reactions (e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock), including very rare reports of death attributed to anaphylaxis.

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